ATTUNE 1547-04-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295382713), received between Jul 20, 2020 and Jul 20, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PAIN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 25871412 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. NEW FEMUR AND INSERT IMPLANTED. NO FURTHER INFORMATION AVAILABLE. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO REPORTED LOOSENING. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 14399847 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. NEW FEMUR AND INSERT IMPLANTED. NO FURTHER INFORMATION AVAILABLE. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO REPORTED LOOSENING. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 14397543 ↗
• InjuryMay 17, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO TREAT INFECTION AND LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS UTILIZED. PATIENT RECEIVED A TEMPORARY SPACER. DOI: (B)(6) 2019; DOR: (B)(6) 2021; UNKNOWN KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11838976 ↗
• InjuryMar 19, 2021Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FROM A COMPETITOR TKA TO AN ATTUNE REVISION KNEE. ALL OF THE PROPER PREP AND 1MM OVER REAM OF THE STEMS WAS DONE. THE TRIAL SAT PERFECTLY AND THE REAL IMPLANT WAS CONSTRUCTED TO LOOK EXACTLY LIKE THE TRIALS. THE REAL FEMORAL CONSTRUCT WOULD NOT SEAT FULLY. IT SAT 12MM PROUD AND RESULTED IN THE KNEE BEING MISBALANCED IN FLEXION AND EXTENSION. THERE WAS A 3 MINUTE SURGICAL DELAY.

  Patient problems: Joint Laxity

  MAUDE report 11529210 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE STIFFNESS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): 08/10/2019; (RIGHT KNEE).

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10378978 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE STIFFNESS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019; (RIGHT KNEE).

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10378976 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND GIVING WAY OF STUDY KNEE WHILE WALKING LONGER DISTANCES. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE). TREATMENT: INVASIVE KNEE ASPIRATION AND PHYSICAL THERAPY.

  Patient problems: No Code Available; Pain

  MAUDE report 10299978 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND GIVING WAY OF STUDY KNEE WHILE WALKING LONGER DISTANCES. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) 2019; (RIGHT KNEE). TREATMENT: INVASIVE KNEE ASPIRATION AND PHYSICAL THERAPY.

  Patient problems: No Code Available; Pain

  MAUDE report 10299975 ↗